Clinical trials: Lower Limb Surgery
Primary Osteoarthritis, Post-traumatic Osteoarthritis of Hip Nos
Observational Study Evaluating Outcomes of Hip Arthroplasty Using Tornier Dual Mobility Acetabular Cup
The purpose of this study is to demonstrate the performance and reliability of Tornier "Dual Mobility Cup" used during primary total hip replacement or hip replacement revision surgery at least 24 months post-insertion.
- Conditions
- Primary Osteoarthritis, Post-traumatic Osteoarthritis of Hip Nos, Femur Head Necrosis, Femur Neck Fracture
- Trial name
- NCT02062450
- Testing
- Primary surgery with Dual Mobility Cup, Revision surgery with Dual Mobility Cup
- Volunteers
- 379 people
- Sponsor
- Stryker Trauma and Extremities
Osteoarthritis, Avascular Necrosis
Post-market Surveillance Study With the HYPERION Hip Endoprosthesis System in Defect Reconstruction
The study is a multi-center, prospective, non-controlled, consecutive cohort post market surveillance study. The objective of this study is to obtain survival and clinical outcome data on the Hyperion® system in primary and…
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Functional Deformities
- Trial name
- NCT03382665
- Where
- 3 sites in Germany
- Volunteers
- 70 people
- Sponsor
- Zimmer Biomet
Diabetic Foot Ulcer, Surgical Wound
The Effect of Natrox® Oxygen Wound Therapy on the Healing Rate of Chronic Diabetic Foot Ulcers
A Multicentre Randomized Controlled Trial to Investigate the Effect of Natrox Topical Oxygen Wound Therapy on the Healing rates of Diabetic Foot Ulcers.
- Trial name
- NCT03905863
- Testing
- Natrox® Oxygen Wound Therapy
- Where
- 20 sites in United States, Puerto Rico
- Volunteers
- 145 people
- Sponsor
- Inotec AMD Limited
Lower Extremity Surgery, Bunion
Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL, EXPAREL Admixed With Bupivacaine HCl vs. Bupivacaine HCl Administered as Combined Sciatic and Saphenous Nerve Blocks for Postsurgical Analgesia in Subjects Undergoing Lower Extremity Surgeries
This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 120 subjects undergoing lower extremity surgeries.
- Conditions
- Lower Extremity Surgery, Bunion, Metatarsophalangeal Fushion, Midfoot Fusion
- Trial name
- STRIDE (NCT04518462)
- Testing
- Exparel, Bupivacaine Hydrochloride
- Where
- 5 sites in United States
- Volunteers
- 121 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Thrombosis, Venous
A Study to Evaluate the Efficacy and Safety of Fondaparinux for the Prevention of Venous Blood Clots in Patients With a Plaster Cast or Other Type of Immobilization for a Below-knee Injury Not Needing Surgery
The purpose of this study is to evaluate the efficacy and safety of fondaparinux in comparison with a heparin (nadroparin) in preventing deep vein thrombosis (blood clots in the leg veins), whether symptomatic or detected by…
- Trial name
- FONDACAST (NCT00843492)
- Testing
- Fondaparinux sodium, Nadroparin
- Where
- 122 sites in France, Germany and 4 more
- Volunteers
- 1,351 people
- Sponsor
- GlaxoSmithKline
Hemostasis
HEMOBLAST Pivotal Clinical Investigation
The purpose of this prospective, randomized, controlled study is to evaluate the safety and efficacy of a new hemostatic device (HEMOBLAST™ Bellows) compared to a control device, absorbable gelatin sponge USP with thrombin.
- Trial name
- NCT02780869
- Testing
- HEMOBLAST Bellows, Absorbable gelatin sponge, USP with thrombin
- Where
- 17 sites in United States
- Volunteers
- 258 people
- Sponsor
- Biom'Up France SAS
Chronic Pain
CoverEdge Algorithm Programming Study
This is a prospective, on-label, multi-center, non-randomized, exploratory, single-arm study to characterize the effects of programming features of the Boston Scientific Precision Spectra™ Spinal Cord Stimulator (SCS) System…
- Trial name
- NCT02492880
- Testing
- Precision Spectra™ SCS system programming features
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Boston Scientific Corporation
Leg Ulcer, Diabetic Foot Ulcer
Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia
The purpose of this reseach study is to determine Mölnlycke Health Care´s Leia dressing performance properties is fulfilled and that the dressing is safe when used on wound types such as pressure ulcer, leg ulcer, and diabetic…
- Conditions
- Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer
- Trial name
- NCT01966380
- Testing
- Leia
- Where
- Sweden
- Volunteers
- 6 people
- Sponsor
- Molnlycke Health Care AB
Leg Ulcers Venous, Dehiscence, Surgical Wound
Blu Light for Ulcers Reduction
Multi-center study on the effectiveness of treatment with a blue light medical device (EmoLED) in the reduction of ulcer surface in 10 weeks.
- Trial name
- BLUR (NCT04018924)
- Testing
- Illumination with blue light (400-430nm) for 60 seconds with a power density of 120mW/sqcm (EmoLED device)
- Where
- 7 sites in Italy
- Volunteers
- 90 people
- Sponsor
- Emoled
Chronic Pain
SCS as an Option for Chronic Low Back and/or Leg Pain Instead of Surgery
To evaluate the safety and effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities compared to Conventional Medical Management (CMM) in patients with chronic low back and/or leg pain who have not undergone spinal…
- Trial name
- SOLIS (NCT04676022)
- Testing
- WaveWriter, Conventional Medical Managament
- Where
- 23 sites in United States
- Volunteers
- 241 people
- Sponsor
- Boston Scientific Corporation
Venous Leg Ulcer
Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers
This study randomly assigns patients with venous leg ulcers to receive standard therapy (compression) alone or compression plus Dermagraft(R).
- Trial name
- DEVO (NCT00909870)
- Testing
- Dermagraft(R), Profore
- Where
- 70 sites in United States, Austria and 6 more
- Volunteers
- 537 people
- Sponsor
- Organogenesis
Surgical Wound, Bilateral Total Knee Arthroplasty
Evaluating Edema and Range of Motion Using Negative Pressure Therapy vs. Standard Surgical Dressing in Bilateral TKA
This study will compare the effects of closed incision negative pressure dressing vs. standard of care silver dressing on lower limb swelling after bilateral primary total knee arthroplasty.
- Conditions
- Surgical Wound, Bilateral Total Knee Arthroplasty, Wounds and Injuries, Joint Diseases
- Trial name
- ENABLE (NCT04712019)
- Testing
- Closed Incision Negative Pressure Therapy (ciNPT), Standard Silver-containing Dressing
- Where
- 6 sites in United States
- Volunteers
- 10 people
- Sponsor
- Solventum US LLC
Short Duration Lower Limb Surgery Via Spinal Anaesthesia
Spinal Anaesthesia With Chloroprocaine HCl 1% for Elective Lower Limb Procedures of Short Duration.
This study evaluate the effect of 3 doses of Chloroprocaine HCl 1% (30, 40 and 50 mg) for spinal anaesthesia in adult patients undergoing short duration elective surgery of the lower limb.
- Trial name
- NCT02481505
- Testing
- Chloroprocaine HCl 1%
- Where
- Italy
- Volunteers
- 45 people
- Sponsor
- Sintetica SA
Surgical Incision, Ulcer Foot
Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds
This is a prospective, multi-center, open label study evaluating the performance of PICO14 Negative Pressure Wound Therapy (NPWT) in the management of chronic open wounds (pressure ulcers, venous leg ulcers, diabetes related foot…
- Conditions
- Surgical Incision, Ulcer Foot, Ulcer Venous, Ulcer, Leg
- Trial name
- PICO14 (NCT05234632)
- Testing
- PICO 14 single-use Negative Pressure Wound Therapy System
- Where
- 6 sites in Germany, United Kingdom
- Volunteers
- 45 people
- Sponsor
- Smith & Nephew, Inc.
Venous Reflux
VenaSeal Spectrum: Global Post-Market Randomized Controlled Trial
Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early and Advanced Stage Superficial Venous…
- Trial name
- NCT03820947
- Testing
- VenaSeal™ System, Endothermal Ablation (ETA), Surgical Stripping
- Where
- 32 sites in United States, Australia and 8 more
- Volunteers
- 506 people
- Sponsor
- Medtronic Endovascular
Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease
Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease
The PATHFINDER Registry is a prospective, non-randomized, single arm, multicenter observational study. This pilot registry is aimed to evaluate the performance (peri-procedural) and clinical outcomes (intermediate and long-term)…
- Conditions
- Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease, PAD
- Trial name
- PATHFINDER (NCT04229563)
- Testing
- AURYON Atherectomy System
- Where
- 10 sites in United States
- Volunteers
- 102 people
- Sponsor
- Angiodynamics, Inc.
Femoral Fractures
Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Surgery For Long Bone Fracture
Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in a number of types of surgery.
- Trial name
- NCT00824564
- Testing
- Tranexamic Acid plus standard of care, Standard of care
- Where
- India
- Volunteers
- 82 people
- Sponsor
- Pfizer
Hemostasis
HEMOBLAST Pilot Clinical Investigation
The primary objective of this pilot clinical investigation is to assess the reliability of the Surface Bleeding Severity Scale (SBSS) in a clinical setting.
- Trial name
- NCT02502019
- Testing
- HEMOBLAST Bellows
- Where
- 3 sites in United States
- Volunteers
- 27 people
- Sponsor
- Biom'Up France SAS
Fracture Healing
Study To Assess FRacTure Healing With SclerosTin Antibody - Hip
This is an international, multi-center study to determine the efficacy, safety, and tolerability of romosozumab (AMG 785) in adults with a fresh unilateral hip fracture, status post surgical fixation.
- Trial name
- STARTT-Hip (NCT01081678)
- Testing
- Romosozumab
- Where
- 99 sites in United States, Argentina and 22 more
- Volunteers
- 332 people
- Sponsor
- Amgen
Venous Thromboembolism
Safety and Pharmacokinetics Study of DU-176b Administered to Patients With Severe Renal Impairment Undergoing Orthopedic Surgery of The Lower Limbs
To assess the safety and pharmacokinetics of DU-176b administered to patients with severe renal impairment undergoing orthopedic surgery of the lower limbs, compared with DU-176b administered to patients with mild renal…
- Trial name
- NCT01857583
- Testing
- 15mg DU-176b, 30mg DU-176b, Fondaparinux
- Where
- Japan
- Volunteers
- 80 people
- Sponsor
- Daiichi Sankyo Co., Ltd.